BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGETICS

    MDR report key: 5650332 · Received February 12, 2016

    Report

    Report Number
    1932402-2014-00002
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    January 16, 2014
    Report Date
    February 11, 2014
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONDITION OF SAMPLE SUGGESTS THAT INSTRUMENTATION SNAGGED THE POLY CANNULA CAUSING A DEFECT. THE DEFECT SUBSEQUENTLY RESULTED IN FAILURE OF CANNULA.

    Description of Event or Problem · 1

    DEVICE USED AS PORT SITE FOR SURGICAL INTERVENTION. NEAR THE END OF THE EYE SURGERY, CANNULA WAS BEING REMOVED. THE HUB PORTION SEPARATED FROM THE CANULA PORTION. THE CANNULA PORTION DROPPED DOWN INTO THE PATIENT'S VITREOUS. CANNULA RETRIEVED INTACT. ADDITIONAL VITRECTOMY REQUIRED TO RETRIEVE THE CANNULA, AS WELL AS ADDITIONAL LASER USE AS A CAUTIONARY MEASURE TO STABILIZE THE RETINA. NO HARM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93028 SYNERGETICS HMX SYNERGETICS, INC. 58.23 M250700

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention